N-Eegx
N-Eegx MJS101, N-Eegx Headbox Assembly USA
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | GE Healthcare Finland OY, Finland |
|---|---|
| FDA product code | OMC |
| Device type | Reduced- Montage Standard Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K191322 |
| Record published | 2022-07-01 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 10 to 40 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH; Handling environment humidity 10 to 90 % RH; Storage environment temperature -25 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MJS101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| X-Series | Advanced Brain Monitoring, Inc. | 59 |
| Sleep Profiler PSG2 | Advanced Brain Monitoring, Inc. | 22 |
| Sleep Profiler | Advanced Brain Monitoring, Inc. | 13 |
| Remi | Epitel | 12 |
| Natus | Xltek | 5 |
| Narcotrend Patient lead | MT Monitortechnik Gmbh & Co. KG | 2 |
| Reduced- Montage Standard Electroencephalograph | GE Healthcare Finland OY | 2 |
| Quex S | QX World KFT | 2 |
| AE-120A EEG Head Set | Nihon Kohden Corp. | 2 |
| VitalEEG Portable System | Nihon Kohden America, Inc. | 2 |
| Nurochek-Pro | Headsafe MFG PTY Ltd | 2 |
| Quex ED | QX World KFT | 2 |
Showing 12 of 87. All products under Reduced- Montage Standard Electroencephalograph
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.